HUMAN IMMUNODEFICIENCY VIRUS AND CYTOMEGALOVIRUS VIRAL BURDEN

人类免疫缺陷病毒和巨细胞病毒的病毒负担

• 批准号: 6291137
• 负责人: MICHAEL FRANK
• 金额: $ 0.04万
• 依托单位: INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6291137
• 关键词: AIDS; CD4 molecule; CD8 molecule; HIV infections; blood chemistry; clinical research; communicable disease diagnosis; cytomegalovirus; cytomegalovirus retinitis; human immunodeficiency virus; human mortality; human subject; longitudinal human study; pathologic process; virus DNA; virus RNA

This is a prospective, multicenter, observational study of HIV-infected subjects who are CMV-seropositive and who have not had clinical symptoms of CMV disease at study entry. Subjects will be followed for three years or until the diagnosis of CMV end-organ disease, or death, whichever comes first. Clinical evaluations will be performed at baseline and every 8 weeks. Blood samples for virologic studies will be obtained every 16 weeks. Blood samples will also be stored every 16 weeks for future immunologic studies. Routine clinical evaluations will be performed prior to enrollment and every 8 weeks for the duration of the study. Ophthalmologic evaluations will be performed at baseline and at 24-week intervals, as well as whenever symptoms indicate a need for a diagnostic evaluation for CMV retinitis. CD4/CD8 counts will be monitored and plasma and polymorphonuclear blood leukocytes will be stored for quantitative HIV RNA and CMV DNA studies at baseline, 16-week intervals, and whenever CMV end-organ disease is diagnosed. Evaluations for non-ocular disease will be performed when clinically indicated and according to predetermined guidelines. Co-enrollment will be permitted in other ACTG studies. This study aims to analyze in detail the relationships between HIV load, CMV load, and CMV end-organ disease in patients with AIDS who are at risk for developing this complication. In addition, the study will describe the natural history of CMV infection in patients receiving a variety of antiretroviral therapies (including HAART), or no anti-HIV therapy at all.

这是一项前瞻性、多中心、观察性研究，受试者为CMV血清阳性且在入组研究时无CMV疾病临床症状的HIV感染受试者。 受试者将随访3年或直至诊断为CMV终末器官疾病或死亡，以先发生者为准。 将在基线时和每8周一次进行临床评价。 将每16周采集一次用于病毒学研究的血样。 血液样本也将每16周储存一次，用于未来的免疫学研究。将在入组前和研究期间每8周一次进行常规临床评价。 将在基线时和每隔24周进行一次眼科评价，以及当症状表明需要对CMV视网膜炎进行诊断评价时进行眼科评价。将监测CD 4/CD 8计数，并储存血浆和多形性血白细胞，用于基线、16周间隔和诊断CMV终末器官疾病时的定量HIV RNA和CMV DNA研究。 当有临床指征时，将根据预定指南进行非眼部疾病的评价。其他ACTG研究将允许联合入组。本研究的目的是详细分析艾滋病病毒载量，巨细胞病毒载量和巨细胞病毒终末器官疾病的艾滋病患者谁是在发展这种并发症的风险之间的关系。 此外，该研究将描述接受各种抗逆转录病毒治疗（包括HAART）或根本没有抗HIV治疗的患者中CMV感染的自然史。